Tetherless Biopsy Device with Reusable Portion

ABSTRACT

A biopsy device comprises a body, a needle, and a cutter actuation mechanism. The needle extends distally from the body. The cutter actuation mechanism rotates and translates the cutter relative to the body and relative to the needle. The cutter has an overmold presenting a lead screw and a hex portion. The cutter actuation mechanism comprises a first gear disposed about the hex portion of the overmold and a second gear engaged with the lead screw of the overmold by a nut that is integral with the second gear. The cutter actuation mechanism is operable to simultaneously rotate the first gear relative to the body at a first rotational speed and the second gear relative to the body at a second rotational speed. With the lead screw and the nut rotating at different rotational speeds, the lead screw rotates relative to the nut at a third rotational speed.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, or otherwise. For instance, some biopsy devicesmay be fully operable by a user using a single hand, and with a singleinsertion, to capture one or more biopsy samples from a patient. Inaddition, some biopsy devices may be tethered to a vacuum module and/orcontrol module, such as for communication of fluids (e.g., pressurizedair, saline, atmospheric air, vacuum, etc.), for communication of power,and/or for communication of commands and the like. Other biopsy devicesmay be fully or at least partially operable without being tethered orotherwise connected with another device.

Merely exemplary biopsy devices are disclosed in U.S. Pat. No.5,526,822, entitled “Method and Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,086,544, entitled “Control Apparatus for an Automated Surgical BiopsyDevice,” issued Jul. 11, 2000; U.S. Pub. No. 2003/0109803, entitled “MRICompatible Surgical Biopsy Device,” published Jun. 12, 2003; U.S. Pub.No. 2006/0074345, entitled “Biopsy Apparatus and Method,” published Apr.6, 2006; U.S. Pub. No. 2007/0118048, entitled “Remote Thumbwheel for aSurgical Biopsy Device,” published May 24, 2007; U.S. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008; U.S. Non-Provisional patent application Ser. No.11/964,811, entitled “Clutch and Valving System for Tetherless BiopsyDevice,” filed Dec. 27, 2007; U.S. Non-Provisional patent applicationSer. No. 12/335,578, entitled “Hand Actuated Tetherless Biopsy Devicewith Pistol Grip,” filed Dec. 16, 2008; and U.S. Non-Provisional patentapplication Ser. No. 12/337,942, entitled “Biopsy Device with CentralThumbwheel,” filed Dec. 18, 2008. The disclosure of each of theabove-cited U.S. patents, U.S. Patent Application Publications, and U.S.Non-Provisional Patent Application is incorporated by reference herein.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventors hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a perspective view of an exemplary biopsy device;

FIG. 2 depicts a perspective view of the biopsy device of FIG. 1, with aprobe portion separated from a holster portion;

FIG. 3 depicts a side cross-sectional view of the biopsy device of FIG.1, with the probe portion separated from the holster portion;

FIG. 4 depicts a perspective view of the biopsy device of FIG. 1, withhousing components removed;

FIG. 5 depicts an exploded view of the biopsy device components of FIG.4, with portions shown in cross-section, and with a battery and acircuit board removed;

FIG. 6 depicts a side cross-sectional view of the biopsy device of FIG.1;

FIG. 7 depicts a perspective view of drive train components of thebiopsy device of FIG. 1;

FIG. 8 depicts an exploded view of cutter and needle components of thebiopsy device of FIG. 1, with portions shown in cross-section;

FIG. 9 depicts a perspective cross-sectional view of a needle portion ofthe biopsy device of FIG. 1, with the cutter in a distal-most position;

FIG. 10 depicts a perspective cross-sectional view of cutter actuationmechanism and valve mechanism components of the biopsy device of FIG. 1,with the cutter in the distal-most position of FIG. 9;

FIG. 11 depicts a side cross-sectional view of the components of FIG.10, with the cutter in the distal-most position of FIG. 9;

FIG. 12 depicts a perspective cross-sectional view of a needle portionof the biopsy device of FIG. 1, with the cutter in a partially retractedposition;

FIG. 13 depicts a perspective cross-sectional view of the components ofFIG. 10, with the cutter in the partially retracted position of FIG. 12;

FIG. 14 depicts a side cross-sectional view of the components of FIG.10, with the cutter in the partially retracted position of FIG. 12;

FIG. 15 depicts a perspective cross-sectional view of a needle portionof the biopsy device of FIG. 1, with the cutter in a retracted position;

FIG. 16 depicts a perspective cross-sectional view of the components ofFIG. 10, with the cutter in the retracted position of FIG. 15;

FIG. 17 depicts a side cross-sectional view of the components of FIG.10, with the cutter in the retracted position of FIG. 15;

FIG. 18 depicts a perspective cross-sectional view of a needle portionof the biopsy device of FIG. 1, with the cutter re-advanced to thedistal-most position of FIG. 9;

FIG. 19 depicts a perspective cross-sectional view of the components ofFIG. 10, with the cutter re-advanced to the distal-most position of FIG.9; and

FIG. 20 depicts a side cross-sectional view of the components of FIG.10, with the cutter re-advanced to the distal-most position of FIG. 9.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

Overview

As shown in FIGS. 1-3 (among others), an exemplary biopsy device (10)comprises a needle (20), a body (30), and a tissue sample holder (40).In particular, needle (20) extends distally from the distal portion ofbody (30), while tissue sample holder (40) extends proximally from theproximal portion of body (30). Body (30) is sized and configured suchthat biopsy device (10) may be operated by a single hand of a user. Inparticular, and as described in greater detail below, a user may graspbody (30) with a single hand, insert needle (20) into a patient'sbreast, and collect one or a plurality of tissue samples from within thepatient's breast, all with just using a single hand. Alternatively, auser may grasp body (30) with more than one hand and/or with any desiredassistance. In some settings, the user may capture a plurality of tissuesamples with just a single insertion of needle (20) in the patient'sbreast. Such tissue samples may be pneumatically deposited in tissuesample holder (40), as described in greater detail below, then retrievedfrom tissue sample holder (40) for analysis.

Body (30) of the present example comprises a probe (12) and a holster(14). As shown in FIGS. 2-3, and as described in greater detail below,probe (12) is separable from holster (14). In particular, probe (12) andholster (14) may be removably coupled using bayonet mounts (not shown)or any other suitable structures or features. Use of the term “holster”herein should not be read as requiring any portion of probe (12) to beinserted into any portion of holster (14). Indeed, in some variations ofbiopsy device (10), probe (12) may simply sit on holster (14). In someother variations, a portion of holster (14) may be inserted into probe(12). Furthermore, in some biopsy devices (10), probe (12) and holster(14) may be of unitary or integral construction, such that the twocomponents cannot be separated. By way of example only, in versionswhere probe (12) and holster (14) are provided as separable components,probe (12) may be provided as a disposable component, while holster (14)may be provided as a reusable component. Still other suitable structuraland functional relationships between probe (12) and holster (14) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Some variations of biopsy device (10) may include one or more sensors(not shown), in probe (12) and/or in holster (14), that is/areconfigured to detect when probe (12) is coupled with holster (14). Suchsensors or other features may further be configured to permit onlycertain types of probes (12) and holsters (14) to be coupled together.In addition or in the alternative, such sensors may be configured todisable one or more functions of probes (12) and/or holsters (14) untila suitable probe (12) and holster (14) are coupled together. Of course,such sensors and features may be varied or omitted as desired.

While examples described herein refer to the acquisition of biopsysamples from a patient's breast, it should be understood that biopsydevice (10) may be used in a variety of other procedures for a varietyof other purposes and in a variety of other parts of a patient'sanatomy.

Exemplary Needle

As shown in FIGS. 8-9 (among others), needle (20) of the present examplecomprises a cannula (21) with a tissue piercing tip (22), a lateralaperture (24), a first lumen (26), and a second lumen (28). Tissuepiercing tip (22) is configured to pierce and penetrate tissue, withoutrequiring a high amount of force, and without requiring an opening to bepre-formed in the tissue prior to insertion of tip (22). A cutter (50)is disposed in first lumen (26), and is operable to rotate and translatewithin first lumen (26) as will be described in greater detail below.Lateral aperture (24) is located proximal to tip (22), is in fluidcommunication with first lumen (26), and is configured to receive tissuewhen needle (20) is inserted in a breast and when a cutter (50) isretracted as will also be described in greater detail below. A pluralityof openings (27) provide fluid communication between first and secondlumens (26, 28). A plurality of external openings (not shown) may alsobe formed in needle (20), and may be in fluid communication with secondlumen (28). Examples such external openings are disclosed in U.S. Pub.No. 2007/0032742, entitled “Biopsy Device with Vacuum Assisted BleedingControl,” published Feb. 8, 2007, the disclosure of which isincorporated by reference herein. Of course, as with other componentsdescribed herein, such external openings are merely optional.

Needle (20) of the present example further comprises a hub (200), asshown in FIGS. 8 and 10-11 (among others). Hub (200) may be formed ofplastic that is overmolded about needle (20) or otherwise secured toneedle (20), such that hub (200) is unitarily secured to needle (20).Alternatively, hub (200) may be formed of any other suitable materialthrough any suitable process and may have any other suitablerelationship with needle (20).

Hub (200) of the present example comprises a sleeve portion (204).Sleeve portion (204) extends integrally into probe portion (12) of body(30). As shown in FIGS. 8 and 10-11 (among others), sleeve portion (204)defines a hollow interior (206), which is in fluid communication withsecond lumen (28) of needle (20). Sleeve portion (204) also defines aplurality of openings (208), which are radially spaced about theperimeter of sleeve portion (204) at a common longitudinal position, andwhich are in fluid communication with hollow interior (206). Openings(208) are exposed to ambient air, such that openings (208) provide avent in the present example. Openings (208) are selectively fluidlycoupled with second lumen (28) of needle (20) in this example, as willbe described in greater detail below. In particular, openings (208) areselectively coupled with second lumen (28) during use of biopsy device(10), to selectively provide venting to second lumen (28). A pair ofo-rings (210) are positioned about a shuttle valve slider (152), tosubstantially seal second lumen (28) relative to openings (208) whensecond lumen (28) is not to be vented, depending on the longitudinalposition of slider (152) as will be described in greater detail below. Aseal (212) is also provided at the proximal end of sleeve (204), at theinterface of cutter (50) and sleeve (204). Seal (212) is configured tosubstantially seal the interface of cutter (50) and sleeve (204), evenas cutter (50) rotates and translates relative to sleeve (204). Inparticular, seal (212) sealingly engages a smooth portion (254) of asleeve (250) that is unitarily secured to cutter (50) as will bedescribed in greater detail below.

It should be understood that, as with other components described herein,needle (20) may be varied, modified, substituted, or supplemented in avariety of ways; and that needle (20) may have a variety of alternativefeatures, components, configurations, and functionalities. By way ofexample only, needle (20) may simply lack second lumen (28) altogetherin some versions, such that first lumen (26) is the only lumen definedby needle (20). As another merely exemplary alternative, biopsy device(10) may be configured such that needle (20) may be fired distallyrelative to body (30), such as to assist in penetration of tissue. Suchfiring may be provided by one or more actuators (e.g., solenoid,pneumatic cylinder/piston, etc.), by one or more springs, or in anyother suitable fashion. Other suitable alternative versions, features,components, configurations, and functionalities of needle (20) will beapparent to those of ordinary skill in the art in view of the teachingsherein. Similarly, other suitable modifications to other components ofbiopsy device (10) that may be made in accordance with variations ofneedle (20) (e.g., modifying or omitting valve mechanism (150) inversions where second lumen (28) is omitted from needle (20), etc.) willbe apparent to those of ordinary skill in the art in view of theteachings herein.

Exemplary Body

As noted above, body (30) of the present example comprises a probeportion (12) and a holster portion (14). As shown in FIGS. 3-4 and 6(among others), a battery (34), a pair of circuit boards (35), a motor(36), and a vacuum pump (38) are provided within probe portion (12).Battery (34) may comprise a rechargeable battery, a non-rechargeablebattery, or any other type of battery. For instance, if battery (34) isrechargeable, biopsy device (10) may permit recharging of battery (34)by inserting holster (14) into a recharging station, by allowing removalof battery (34) for recharging, by providing a port for coupling a powercord with holster (14) to allow operation of biopsy device (10) whilesimultaneously recharging battery (34), or in any other suitablefashion. In addition, battery (34) may provide any suitable voltage, andmay be configured to provide power for at least five biopsy proceduresor any other suitable number of procedures before requiring a rechargeor replacement. In other versions, biopsy device (10) is powered by someother source, such as a conventional AC power source or piece of capitalequipment, such that battery (34) is merely optional. Battery (34) iscoupled with motor (36) via circuit boards (35) and a trigger button(not shown) in the present example.

As shown in FIGS. 3-6, motor (36) of the present example is inmechanical communication with vacuum pump (38) and a cutter actuationmechanism (60). In particular, motor (36) is operable to simultaneouslyactivate vacuum pump (38) and cutter actuation mechanism (60) when motor(36) is activated. Alternatively, vacuum pump (38) and cutter rotationmechanism (60) may be activated in any other suitable fashion. By way ofexample only, vacuum pump (38) and/or cutter rotation mechanism (60) maybe activated manually and/or by separate motors and/or in any othersuitable fashion. Motor (36) of the present example comprises aconventional DC motor. However, it should be understood that motor (36)may alternatively comprise a pneumatic motor (e.g., with impeller,etc.), a pneumatic linear actuator, an electromechanical linearactuator, or a variety of other types of movement-inducing devices.Various suitable ways in which other types of movement-inducing devicesmay be incorporated into biopsy device (10) will be apparent to those ofordinary skill in the art in view of the teachings herein.

As shown in FIGS. 3-7, a drive shaft (62) extends from motor (36), andis rotationally driven by motor (36). A pair of bearings (70) and adrive gear (72) are positioned about drive shaft (62). Bearings (70)support drive shaft (62), while drive gear (72) rotates unitarily withdrive shaft (62). In particular, motor (36) may be selectively activatedto rotate drive shaft (62) and drive gear (72) in either rotationaldirection. Drive gear (72) meshes with a second gear (74), which isunitarily secured to a second shaft (64). Second shaft (64) alsoincludes associated bearings (70) and a third gear (76). Second shaft(64) and gears (74, 76) rotate unitarily, such that motor (36) isoperable to rotatingly drive second shaft (64) and gears (74, 76) viadrive shaft (62) and drive gear (72).

Vacuum pump (38) of the present example comprises a conventionaldiaphragm pump. In particular, a second shaft (64), which isrotationally driven by motor (36) as described above, is coupled with aneccentric disk (not shown—e.g., a device for converting circular motioninto rectilinear motion, comprising a disk fixed off-center to secondshaft (64)), which is configured to cause a rod (not shown—e.g., the rodmay be coupled with or otherwise driven by the eccentric disk) of vacuumpump (38) to reciprocate as motor (36) and shafts (62, 64) rotate. Thisrod of vacuum pump (38) drives a diaphragm (not shown) of vacuum pump(38) as the rod reciprocates, causing vacuum pump (38) to induce avacuum. It should be understood that vacuum pump (38) of the presentexample operates in the same way regardless of which direction motor(36) rotates. Of course, any other suitable type of vacuum pump may beused. Vacuum pump (38) of the present example is operable to induce avacuum in tissue sample holder (40) when vacuum pump (38) is activated,as will be described in greater detail below. Cutter actuation mechanism(60) is operable to rotate and translate cutter (50) when cutterrotation mechanism (60) is activated, as will also be described ingreater detail below. In particular, cutter actuation mechanism (60) isoperable to cause cutter (50) to rotate within first lumen (26) andconcomitantly cause cutter (50) to translate within first lumen (26),such as to sever a biopsy sample from tissue protruding through lateralaperture (24).

It should be understood that, as with other components described herein,body (30) may be varied, modified, substituted, or supplemented in avariety of ways; and that body (30) may have a variety of alternativefeatures, components, configurations, and functionalities. Suitablealternative versions, features, components, configurations, andfunctionalities of body (30) will be apparent to those of ordinary skillin the art in view of the teachings herein.

Exemplary Valve Mechanism

As shown in FIGS. 5-6, 8, and 10-11 (among others), biopsy device (10)also includes a valve mechanism (150) in the present example. Valvemechanism (150) of this example comprises shuttle valve slider (152),o-rings (210), and sleeve (204) of needle hub (200). Shuttle valveslider (152) is positioned coaxially about cutter (50), and isconfigured to translate relative to sleeve (204) and relative to cutter(50). In particular, shuttle valve slider (152) is positioned aboutcutter (50) longitudinally between the distal end of sleeve (250) andthe proximal end of a stop member (55), which is unitarily secured tocutter (50). O-rings (210) are configured to seal the exterior ofshuttle valve slider (152) against the interior sidewall of sleeve(204). Shuttle valve slider (152) defines an inner diameter that isgreater than the outer diameter defined by cutter (50), such that a gapis provided between the outer diameter of cutter (50) and the innerdiameter of shuttle valve slider (152). Such a gap is sufficient toprovide longitudinal fluid communication (e.g., atmospheric air, etc.)between the outer diameter of cutter (50) and the inner diameter ofshuttle valve slider (152). In addition, the proximal end of shuttlevalve slider (152) has notches (153) formed in it, providing anappearance similar to that of a castellated nut or castle nut. Theproximal end of shuttle valve slider (152) is also configured to beengaged by the distal end of smooth portion (254) of sleeve (250), suchthat sleeve (250) may push shuttle valve slider distally as describedbelow. Notches (153) are configured to provide fluid communication tothe interior of shuttle valve slider (152), even as the distal end ofsmooth portion (254) of sleeve (250) engages the proximal end of shuttlevalve slider (152).

As described in greater detail below, cutter (50) is configured torotate and translate relative to body (30), while sleeve (204) remainssubstantially stationary relative to body (30). As noted above, sleeve(250) and stop member (55) translate unitarily with cutter (50). Inaddition, stop member (55) and shuttle valve slider (152) are configuredsuch that stop member (55) may push shuttle valve slider (152)proximally when stop member (55) is engaged with shuttle valve slider(152); while sleeve (250) and shuttle valve slider (152) are configuredsuch that sleeve (250) may push shuttle valve slider (152) distally whensleeve (250) is engaged with shuttle valve slider (152). Shuttle valveslider (152) may thus translate within sleeve (250) in accordance withtranslation of cutter (50) relative to body (30). However, the distancebetween the distal end of sleeve (250) and the proximal end of stopmember (55) is greater than the length of shuttle valve slider (152),such that there is a degree of “lost motion” between shuttle valveslider (152) and cutter (50) as cutter (50) translates in the presentexample. In other words, shuttle valve slider (152) remainssubstantially stationary during certain stages of a cutter (50)actuation stroke (see, e.g., FIGS. 12-14), such that shuttle valveslider (152) only translates when cutter (50) approaches the distal-mostposition (see, e.g., FIGS. 18-20) and the proximal-most position (see,e.g., FIGS. 15-17).

As noted above, openings (208) of sleeve (204) communicate with ambientair; and shuttle valve slider (152) is operable to selectively ventsecond lumen (28) to atmosphere. In particular, shuttle valve slider(152) remains distal to openings (208) when cutter (50) is at adistal-most position (see, e.g., FIGS. 9-11 and 18-20); when cutter (50)is transitioning between the distal-most position and the proximal-mostposition (see, e.g., FIGS. 12-14); and at latter stages of cutter (50)transitioning from the proximal-most position to the distal-mostposition. During these stages of operation, second lumen (28) is exposedto ambient air via openings (208) in sleeve (204), notches (153) inshuttle valve slider (152), the gap between the inner diameter ofshuttle valve slider (152) and the outer diameter of cutter (50), andthe portion of sleeve interior (206) that is distal to shuttle valveslider (152). However, shuttle valve slider (152) and o-rings (210)substantially seal second lumen (28) relative to openings (208) whencutter (50) is in a proximal position, such as is shown in FIGS. 15-17.In particular, when cutter (50) moves to the proximal position, stopmember (55) pushes shuttle valve slider (152) proximally such thatopenings (208) are longitudinally positioned between o-rings (210).O-rings (210) thus substantially seal off openings (208) when openings(208) are between o-rings (210). When cutter (50) begins moving againdistally toward the distal-most position, shuttle valve slider (152)remains at this proximal position momentarily, continuing tosubstantially seal second lumen (28) relative to openings (208), untilthe distal end of sleeve (250) engages the proximal end of shuttle valveslider (152) and begins pushing shuttle valve slider (152) distally tothe point where the proximal-most o-ring (210) is moved distal toopenings (208). Once the proximal-most o-ring (210) moves distal toopenings (208), second lumen (28) is again vented as noted above. Thus,valve mechanism (150) of the present example substantially seals offsecond lumen (28) relative to atmosphere when cutter (50) is at aproximal position and when cutter (50) is at initial stages ofadvancement; while venting second lumen (28) to atmosphere when cutter(50) is at other positions.

It should be understood that, as with other components described herein,valve mechanism (150) may be varied, modified, substituted, orsupplemented in a variety of ways; and that valve mechanism (150) mayhave a variety of alternative features, components, configurations, andfunctionalities. Suitable alternative versions, features, components,configurations, and functionalities of valve mechanism (150) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Exemplary Tissue Sample Holder

As shown in FIGS. 1-6, tissue sample holder (40) of the present examplecomprises a cap (42), an outer cup (44), and a filter tray (46). Cup(44) is secured to probe (12) in the present example. Such engagementmay be provided in any suitable fashion. Outer cup (44) of the presentexample is substantially transparent, allowing the user to view tissuesamples on filter tray (46), though outer cup (44) may have any othersuitable properties if desired.

Outer cup (44) is in fluid communication with cutter lumen (52) and withvacuum pump (38) in the present example. In particular, outer cup (44)is in fluid communication with cutter lumen (52) via a first port (45);and is in fluid communication with vacuum pump (38) via a second port(47). A conduit (39) couples port (41) of vacuum pump (38) with secondport (47) of outer cup (44). A spring-loaded seal (not shown) or otherfeature may optionally be provided on conduit (39) and/or second port(47) and/or port (41) of vacuum pump (38), to substantially seal tissuesample holder (40) and/or vacuum pump (38) when conduit (39) isdisconnected from tissue sample holder (40) or vacuum pump (38) and/orwhen probe (12) is decoupled from holster (14). In the present example,second port (47) is further coupled with a hydrophobic filter (48),which is in fluid communication with the interior space defined by outercup (44). Hydrophobic filter (48) is configured to permit vacuum pump(38) to induce a vacuum in tissue sample holder (40) while preventingliquids from being communicated from tissue sample holder (40) to vacuumpump (38). In addition to or in lieu of having hydrophobic filter (48) ahighly absorbent material may be provided in tissue sample holder (40)to soak up liquids. Alternatively, liquids may be dealt with in anyother suitable fashion. As described in greater detail below, the vacuumcreated in tissue sample holder (40) by vacuum pump (38) is communicatedto cutter (50) in the present example. In particular, vacuum pump (38)may thus be used to induce a vacuum in cutter lumen (52); with such avacuum being communicated through conduit (39), ports (41, 45, 47), andthe interior of outer cup (44).

Filter tray (46) of the present example has a basket-like configuration,and has plurality of openings (47) formed therethrough. Openings (47)are sized and configured to permit the passage of fluids therethroughwhile preventing the passage of tissue samples therethrough. Filter tray(46) is thus configured to receive tissue samples that are communicatedproximally through cutter (50) as will be described in greater detailbelow. It should be understood that filter tray (46) may take a varietyof alternate forms. By way of example only, a plurality of slits orother features may be formed through filter tray (46) in addition to orin lieu of round openings (47). As another merely illustrativealternative, filter tray (46) may be substituted with a textile meshand/or other structure(s) or component(s).

Cap (42) is removably coupled with outer cup (44) in the presentexample. A pair of latches (56) provide selective engagement between cap(42) and outer cup (44). In particular, latches (56) engage a lip (57)of outer cup (44). Lip (57) has gaps (59) permitting passage of latches(56), such that a user may secure cap (42) to outer cup (44) by aligninglatches (56) with gaps (59), pushing cap (42) onto outer cup (44), thenrotating cap (42) past gaps (59) to engage latches (56) with lip (57).Alternatively, cap (42) may be secured to outer cup (44) in any othersuitable fashion. An o-ring (53) provides a seal when cap (42) isengaged with outer cup (44). A vacuum may thus be maintained withinouter cup (44) when cap (42) is secured to outer cup (44). In operation,a user may remove cap (42) to access tissue samples that have gatheredon filter tray (46) during a biopsy process. In the present example, cap(42) is removed by rotating cap (42) to align latches (56) with gaps(59), then pulling cap (42) off. Of course, cap (42) may be removed fromouter cup (44) in any other suitable fashion.

Tissue sample holder (40) of the present example is configured to holdat least ten tissue samples. Alternatively, tissue sample holder (40)may be configured to hold any other suitable number of tissue samples.It should be understood that, as with other components described herein,tissue sample holder (40) may be varied, modified, substituted, orsupplemented in a variety of ways; and that tissue sample holder (40)may have a variety of alternative features, components, configurations,and functionalities. For instance, tissue sample holder (40) may bealternatively configured such that it has a plurality of discrete tissuesample compartments that may be selectively indexed to cutter lumen(52). Such indexing may be provided automatically or manually. By way ofexample only, tissue sample holder (40) may be configured and operablein accordance with the teachings of U.S. Pub. No. 2008/0195066, entitled“Revolving Tissue Sample Holder for Biopsy Device,” published Aug. 14,2008, the disclosure of which is incorporated by reference herein; U.S.Non-Provisional patent application Ser. No. 12/337,997, entitled “TissueBiopsy Device with Rotatably Linked Thumbwheel and Tissue SampleHolder,” filed Dec. 18, 2008; U.S. Non-Provisional patent applicationSer. No. 12/337,911, entitled “Biopsy Device with Discrete TissueChambers,” filed Dec. 18, 2008, the disclosure of which is incorporatedby reference herein; or U.S. Non-Provisional patent application Ser. No.12/337,874, entitled “Mechanical Tissue Sample Holder Indexing Device,”filed Dec. 18, 2008, the disclosure of which is incorporated byreference herein. Other suitable alternative versions, features,components, configurations, and functionalities of tissue sample holder(40) will be apparent to those of ordinary skill in the art in view ofthe teachings herein. Alternatively, tissue sample holder (40) maysimply be omitted, if desired.

Exemplary Cutter

As shown in FIGS. 8-9 (among others), cutter (50) of the present exampleis substantially hollow, such that cutter (50) defines a cutter lumen(52). Cutter (50) also has a substantially sharp distal edge (51), suchthat cutter (50) is operable to sever a biopsy sample from tissueprotruding through lateral aperture (24) of needle (20). Alternatively,the distal end of cutter (50) may have any other suitable configuration.As shown in FIGS. 3 and 5-6, a proximal portion of cutter (50) extendsinto tissue sample holder (40). A vacuum created in tissue sample holder(40) by vacuum pump (38) is thus communicated to cutter lumen (52). Aseal (54) is provided at the interface of cutter (50) and outer cup(44). Seal (54) is configured to substantially seal the interface ofcutter (50) and mount (42), even as cutter (50) rotates and translatesrelative to outer cup (44). Furthermore, cutter (50) is configured suchthat it remains in sealed fluid communication with the interior oftissue sample holder (40) even when cutter (50) is in a distal mostposition. For instance, the length of cutter (50) may be such that atleast a portion of cutter (50) is always disposed in outer cup (44) oftissue sample holder (40) during operation of biopsy device (10). Ofcourse, cutter (50) may have any other suitable alternative features orconfigurations. Similarly, cutter (50) may have any other suitablealternative relationships with tissue sample holder (40).

It should be understood that, as with other components described herein,cutter (50) may be varied, modified, substituted, or supplemented in avariety of ways; and that cutter (50) may have a variety of alternativefeatures, components, configurations, and functionalities. Suitablealternative versions, features, components, configurations, andfunctionalities of cutter (50) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Exemplary Cutter Actuation Mechanism

As shown in FIGS. 3-7 and 10-11 (among others), cutter actuationmechanism (60) of the present example comprises motor (36), shafts (62,64), and gears (72, 74, 76), each of which are described in greaterdetail above. Cutter actuation mechanism (60) further comprises a fourthgear (78), which meshes with third gear (76). Fourth gear (78) isunitarily secured to a third shaft (68), which is supported in body (30)by bearings (70). A fifth gear (80) is also unitarily secured to thirdshaft (68). Gears (78, 80) thus rotate unitarily with third shaft (68)in this example. Fifth gear (80) meshes with sixth gear (82), which isunitarily secured to a fourth shaft (69). Fourth shaft (69) is alsosupported in body (30) by bearings (70). A seventh gear (84) is alsounitarily secured to fourth shaft (69). Gears (82, 84) thus rotateunitarily with fourth shaft (69) in this example. It should beunderstood in view of the foregoing that activation of motor (36) willrotate gears (82, 84) in the present example. As shown in FIGS. 3 and 6,motor (36), shafts (62, 64, 68, 69), gears (72, 74, 76, 78, 80, 82, 84),and bearings (70) are all contained within holster (14) in the presentexample. As shown in FIG. 2, gears (82, 84) are partially exposed by anopening formed in a cover plate (18) of holster (14) in the presentexample.

Cutter actuation mechanism (60) of the present example further comprisesa hex nut (100) and a worm nut (120). Hex nut (100) includes a gear(86), which is configured to rotate unitarily with hex nut (100). Wormnut (120) also includes a gear (88), which is configured to rotateunitarily with worm nut (120). Gear (86) is configured to mesh with gear(82) when probe (12) and holster (14) are coupled together; while gear(88) is configured to mesh with gear (84) when probe (12) and holster(14) are coupled together. In particular, and as shown in FIG. 2, gears(86, 88) are partially exposed by an opening formed in a cover plate(16) of probe (12) in the present example. Motor (36) is thus operableto rotatingly drive gears (86, 88) in the present example when probe(12) and holster (14) are coupled together. As described in greaterdetail below, such rotation of gears (86, 88) will cause cutter (50) torotate and translate in the present example.

A sleeve (250) is unitarily secured to cutter (50). As best seen in FIG.8, sleeve (250) comprises a hex portion (252), a smooth portion (254),and a flange (256) separating hex portion (252) from smooth portion(254). In the present example, sleeve (250) is overmolded about cutter(50), such that cutter (50) and sleeve (250) rotate and translateunitarily. For instance, sleeve (250) may be formed of a plasticmaterial that is overmolded about a metal cutter (50). Alternatively,any other suitable materials and methods of forming may be used forsleeve (250) and cutter (50), and sleeve (250) may be secured to cutter(50) in any other suitable fashion (e.g., using set screw, bonding,etc.). Hex nut (100) is slidably positioned over hex portion (252) ofsleeve (250). In particular, hex portion (252) of sleeve (250) presentssix flat faces; while hex nut (100) defines a hexagonal opening with sixflat faces that are configured to complement the flat faces of sleeve(250). The engagement between sleeve (250) and hex nut (100) istherefore such that rotation of hex nut (100) provides correspondingrotation of sleeve (250). The engagement between sleeve (250) and hexnut (100) is also such that hex nut (100) may slide longitudinallyrelative to sleeve (250), even as hex nut (100) and sleeve (250)simultaneously rotate. For instance, the longitudinal position of hexnut (100) may stay substantially constant as cutter (50) and sleeve(250) translate longitudinally. Bosses (not shown) are formed in thehousing of probe (12) in the present example to maintain thelongitudinal position of hex nut (100), while also permitting hex nut(100) to rotate. Hex nut (100) is further supported by a bearing (70) inthe present example. It should also be understood that sleeve (250) andhex nut (100) may have a variety of other configurations (e.g.,complementary key and keyway instead of hex features, etc.) andrelationships. Similarly, a variety of other structures or componentsmay be used in addition to or in lieu of sleeve (250) and/or hex nut(100).

As noted above, gear (86) of hex nut (100) is configured to mesh withgear (82), such that rotation of gear (82) causes rotation of hex nut(100). Such rotation of hex nut (100) will cause corresponding rotationof cutter (50) as noted above. It will therefore be understood thatcutter actuation mechanism (60) may cause rotation of cutter (50) inresponse to activation of motor (36), with rotation of motor (36) beingcommunicated to cutter (50) through shafts (62, 64, 68, 69), gears (72,74, 76, 78, 80, 82, 84, 86), hex nut (100), and sleeve (250). Of course,any other suitable structures, components, configurations, or techniquesmay be used to provide rotation of cutter (50).

Cutter actuation mechanism (60) of the present example further comprisesa lead screw (122). Lead screw (122) is positioned about hex portion(252) of sleeve (250), and is configured to rotate unitarily therewith.As noted above, hex portion (252) of sleeve (250) presents six flatfaces. Lead screw (122) defines a hexagonal opening with six flat facesthat are configured to complement the flat faces of sleeve (250). Theengagement between sleeve (250) and lead screw (122) is therefore suchthat rotation of cutter (50) and sleeve (250) provides correspondingrotation of lead screw (122). Lead screw (122) is further secured to hexportion (252) of sleeve (250) by a clip (124). In particular, clip (124)is secured to sleeve (250), and a washer (126) is positioned betweenclip (124) and lead screw (122). Washer (126) and clip (124) areconfigured such that washer (126) may not move proximally past clip(124). A first coil spring (128) is positioned between the proximal endof lead screw (122) and washer (126). A second coil spring (130) ispositioned between the distal end of lead screw (122) and flange (256)of sleeve (250). Flange (256), washer (126), and clip (124) thusrestrict longitudinal motion of lead screw (122) along sleeve (250). Thespacing between flange (256) and washer (126) permit some freedom ofmovement for lead screw (122) along a portion of the length of sleeve(250) between flange (256) and washer (126); while springs (128, 130)bias lead screw (122) to be substantially centered between flange (256)and washer (126). It should be understood that any other suitable typeof resilient member may be used in addition to or in lieu of coilsprings (128, 130).

Lead screw (122) has external threads (132) that are engaged withinternal threads (134) of worm nut (120). Accordingly, lead screw (122)translates relative to worm nut (120) when lead screw (122) rotatesrelative to worm nut (120) when threads (132, 134) are engaged. However,the interior length of worm nut (120) also includes smooth sections(136) that are distal to and proximal to internal threads (134). Thus,lead screw (122) may not translate relative to worm nut (120) when leadscrew (122) rotates relative to worm nut (120) when threads (132) arelocated at smooth sections (136) (e.g., when threads (132, 134) are notengaged). Threads (132) of lead screw (122) are relatively coarse in thepresent example, which may allow repeated engagement and disengagementbetween threads (132, 134) without substantially damaging threads (132).

Bosses (not shown) are formed in the housing of probe (12) in thepresent example to maintain the longitudinal position of worm nut (120),while also permitting worm nut (120) to rotate. Worm nut (120) isfurther supported by a bushing (138) in the present example. It shouldbe understood that, due to engagement of lead screw (122) with flange(256) and washer (126), and due to engagement of sleeve (250) withcutter (250), translation of lead screw (122) relative to worm nut (120)in the present example also results in translation of cutter (50)relative to body (30) in the present example. It should also beunderstood that sleeve (250), lead screw (122), and worm nut (120) mayhave a variety of other configurations and relationships. Similarly, avariety of other structures or components may be used in addition to orin lieu of sleeve (250) and/or worm nut (120).

As noted above, gears (82, 84) of holster (14) rotate simultaneouslywhen motor (36) is activated. As further noted above, gears (82, 84)mesh with gears (86, 88) of probe (12) when probe (12) is coupled withholster (14), such that activated motor (36) rotates gears (86, 88)simultaneously. Activated motor (36) will thus rotate hex nut (100) andworm nut (120) simultaneously. It should therefore be understood thatsleeve (250), cutter (50), lead screw (122), and worm nut (120) will allrotate simultaneously when motor (36) is activated. It is also notedthat gears (82, 84) have different pitch diameters (i.e., the pitchdiameter of gear (82) is different from the pitch diameter of gear(84)). Gears (86, 88) also have different pitch diameters (i.e., thepitch diameter of gear (86) is different from the pitch diameter of gear(88)). Accordingly, even with motor (36) rotating at one rotationalspeed, hex nut (100) and worm nut (120) rotate simultaneously in thesame direction at different rotational speeds. Since rotation of leadscrew (122) is driven by rotation of hex nut (100), lead screw (122) andworm nut (120) also rotate simultaneously in the same direction atdifferent rotational speeds. Even though lead screw (122) and worm nut(120) rotate simultaneously in the same direction, the differencebetween rotational speeds of lead screw (122) and worm nut (120) providea net result of lead screw (122) rotating relative to worm nut (120),such relative rotation provides translation of cutter (50) as cutter(50) rotates. By way of example only, with motor (36) providing anoutput speed of approximately 8,000 rpm, the above-describedconfiguration may provide rotation of cutter (50) at a speed ofapproximately 1,000 rpm and rotation of worm nut (120) at a speed ofapproximately 850 rpm, resulting in a net rotation of cutter (50)relative to worm nut (120) at approximately 150 rpm. Of course, anyother suitable differential may be provided.

In the present example, cutter (50) is retracted proximally when motor(36) is activated to rotate cutter (50) counterclockwise (viewed fromtissue sample holder (40) toward needle (20)); while cutter (50) isadvanced distally when motor (36) is activated to rotate cutter (50)clockwise (viewed from tissue sample holder (40) toward needle (20)).The direction of motor (36) rotation may thus be reversed to transitionbetween distal and proximal translation of cutter (50). Alternatively,cutter actuation mechanism (60) may be configured to be self-reversing,such that cutter (50) may be translated distally and proximally withoutreversing the direction of motor (36) rotation.

In one merely illustrative example of operation of cutter actuationmechanism (100), cutter (50) may be initially located in a distal-mostposition, such that lateral aperture (24) is “closed” as shown in FIG.9; with lead screw (122) being positioned at the distal smooth section(136) of worm nut (120), as shown in FIGS. 10-11. Spring (130) biaseslead screw (122) proximally to engage threads (132) with threads (134).At this stage, clockwise rotation of cutter (50) relative to worm nut(120) will not result in any translation of cutter (50) (e.g., leadscrew (122) will essentially “freewheel”); while counterclockwiserotation of cutter (50) relative to worm nut (120) will result inproximal translation of cutter (50). As cutter (50) is rotated by motor(36) and cutter actuation mechanism (60) in the counterclockwisedirection (viewed from tissue sample holder (40) toward needle (20)),cutter actuation mechanism (100) causes cutter (50) to retractproximally, as shown in FIGS. 12-14. As noted above, such proximal orrearward translation may be effected through engagement of threads (132,134), and due to lead screw (122) rotating at a faster speed than wormnut (120). Lead screw (122) continues to traverse threads (134) of wormnut (120) as cutter (50) continues to retract proximally.

Cutter (50) then reaches a proximal-most position, such that lateralaperture (24) is “opened” as shown in FIG. 15. At this stage, lead screw(122) is positioned at the proximal smooth section (136) of worm nut(120), as shown in FIGS. 16-17. Spring (128) biases lead screw (122)distally to engage threads (132) with threads (134). At this stage,continued counterclockwise rotation of cutter (50) relative to worm nut(120) will not result in any translation of cutter (50) (e.g., leadscrew (122) will essentially “freewheel”); while clockwise rotation ofcutter (50) relative to worm nut (120) will result in distal translationof cutter (50). To that end, motor (36) may again be activated, with itsrotation direction being reversed to reverse the rotation direction ofcutter (50) and associated components. In particular, reversing therotational direction of motor (36) causes cutter (50) to rotateclockwise (viewed from tissue sample holder (40) toward needle (20)).Such clockwise rotation of cutter (50) causes cutter to advance distallyto reach the distal-most position again, as shown in FIGS. 18-20.

While cutter (50) is shown and described above as rotatingcounterclockwise (viewed from tissue sample holder (40) toward needle(20)) during retraction of cutter (50) and clockwise (viewed from tissuesample holder (40) toward needle (20)) during advancement of cutter(50), it should be immediately apparent to those of ordinary skill inthe art that cutter (50) may instead be rotated clockwise duringretraction of cutter (50) and counterclockwise during advancement ofcutter. For instance, such reversal may be provided by reversing theorientation of threads (132, 134). Alternatively, such reversal may beprovided by changing the differential such that worm nut (120) rotatesfaster than cutter (50). Of course, any other suitable structures,components, configurations, or techniques may be used to providetranslation and/or rotation of cutter (50). It should therefore beunderstood that, as with other components described herein, cutteractuation mechanism (60) may be varied, modified, substituted, orsupplemented in a variety of ways; and that cutter actuation mechanism(60) may have a variety of alternative features, components,configurations, and functionalities. By way of example only, biopsydevice (10) may be configured such that cutter (50) does not translate(e.g., such that cutter (50) merely rotates, etc.); or such that cutter(50) does not rotate (e.g., such that cutter (50) merely translates,etc.). Other suitable alternative versions, features, components,configurations, and functionalities of cutter actuation mechanism (60)will be apparent to those of ordinary skill in the art in view of theteachings herein.

Exemplary Pneumatic Operation

As noted above, vacuum pump (38) is operable to induce a vacuum intissue sample holder (40), and such vacuum may be further communicatedto cutter lumen (52). In particular, vacuum pump (38) may start buildinga vacuum in cutter lumen (52) as soon as motor (36) is activated; andsuch a vacuum may continue to build or be maintained as cutter (50)starts moving proximally toward the retraced position. At this stage,second lumen (28) is vented to atmosphere. In particular, shuttle valveslider (152) is in a distal position, allowing atmospheric air to reachsecond lumen (28)—via openings (208), notches (152), the gap between theinner diameter of shuttle valve slider (152) and the outer diameter ofcutter (50), and the portion of sleeve interior (206) that is distal toshuttle valve slider (152)—as shown in FIGS. 10-11. Alternatively,second lumen (28) may be fluidly coupled with vacuum pump (38), suchthat a vacuum is created in second lumen (28) at this stage.

As cutter (50) moves toward retracted position, such that lateralaperture (24) of needle (20) is “partially open” as shown in FIG. 12, avacuum in cutter lumen (52) may be further communicated through firstlumen (26), which may draw tissue into lateral aperture (24). At thisstage, second lumen (28) is still vented to atmosphere. In particular,due to the “lost motion” between cutter (50) and shuttle valve slider(152), shuttle valve slider (152) remains in the distal position despiteproximal retraction of cutter (50), as shown in FIGS. 13-14.Alternatively, second lumen (28) may be fluidly coupled with vacuum pump(38), such that a vacuum is created in second lumen (28) at this stage.In the present example, second lumen (28) is substantially sealed whencutter (50) reaches a longitudinal position that is proximal to theposition shown in FIG. 12, and before cutter (50) reaches the fullyretracted position shown in FIG. 15.

When cutter (50) reaches the fully retracted position, such that lateralaperture (24) of needle (20) is “open” as shown in FIG. 15, a vacuum incutter lumen (52) may continue to be further communicated through firstlumen (26), which may continue to draw tissue into lateral aperture(24). Of course, some amount of tissue may naturally prolapse intolateral aperture (24) without the assistance of vacuum, such that vacuummay not even be needed to draw tissue into lateral aperture (24). Atthis stage, second lumen (28) is substantially sealed relative toatmosphere, as shown in FIGS. 16-17. In particular, stop member (55) haspushed shuttle valve slider (152) to a proximal position, such thato-rings (210) “straddle” openings (208) and seal against the interiorsidewall of sleeve portion (204) to prevent atmospheric air from beingcommunicated from openings (208) to second lumen (28) via hollowinterior (206) of sleeve portion (204).

As motor (36) is reversed and cutter (50) is advanced to sever tissueprotruding through lateral aperture (24), as shown in FIGS. 18-20,vacuum pump (38) may continue to induce a vacuum in cutter lumen (52),and second lumen (28) may eventually be vented to atmosphere. However,in the initial stages of advancement of cutter (50) from theproximal-most position to the distal-most position, the “lost motion”between cutter (50) and shuttle valve slider (152) leaves shuttle valveslider (152) in the proximal position until cutter (50) advances farenough for the distal end of sleeve (250) to engage the proximal end ofshuttle valve slider (152). Until such engagement between the distal endof sleeve (250) and the proximal end of shuttle valve slider (152),o-rings (210) of shuttle valve slider (152) continue to substantiallyseal second lumen (28) from openings (208). After the distal end ofsleeve (250) engages the proximal end of shuttle valve slider (152), andafter cutter (50) has continued to move distally to a sufficient degree,the distal end of sleeve (250) eventually pushes shuttle valve slider(152) distally, such that the proximal-most o-ring (210) is eventuallymoved distal to openings (208). With shuttle valve slider (152) reachingsuch a position (and positions that are further distal to such aposition), second lumen (28) is again vented to atmosphere as describedabove, and as shown in FIGS. 19-20. As cutter (50) again finally reachesthe distal-most position, as shown in FIG. 18, cutter (50) maycompletely sever the tissue protruding through lateral aperture (24),with second lumen (28) being vented as shown in FIGS. 19-20.

With the severed tissue sample residing in cutter lumen (52), withvacuum pump (38) drawing a vacuum at the proximal face of the severedtissue sample, and with the venting being provided at the distal face ofthe severed tissue sample (via openings (208), second lumen (28), andopenings (27)), the pressure differential applied to the severed tissuesample may cause the severed tissue sample to be drawn proximallythrough cutter lumen (52) and into tissue sample holder (40). Thesevered tissue sample may thus be deposited on filter tray (46) oftissue sample holder (40).

Of course, any other suitable structures, components, configurations, ortechniques may be used to provide selective sealing and/or venting ofsecond lumen (28). By way of example only, while shuttle valve slider(152) is actuated mechanically based on the axial position of cutter(50) in the present example, it should be understood that shuttle valveslider (152) or any other type of valve may instead be actuatedelectrically (e.g., via a separate motor or solenoid), pneumatically, orotherwise. Furthermore, in some variations of biopsy device (10), avacuum, saline, pressurized air, atmospheric air, and/or any othermedium may be communicated to second lumen (28) at any suitable stage ofoperation of biopsy device (10) (e.g., applying vacuum or venting tosecond lumen (28) during and/or upon retraction of cutter (50) and/orduring advancement of cutter (50), sealing second lumen duringadvancement of cutter (50), etc.). Suitable alternative structures,components, configurations, or techniques for communicating severedtissue samples proximally through cutter lumen (52) to reach tissuesample holder (40) will be apparent to those of ordinary skill in theart in view of the teachings herein.

Exemplary Method of Operation

In a merely exemplary use of biopsy device (10), a user first insertstissue piercing tip (22) into the breast of a patient. During suchinsertion, cutter (50) may be advanced to the distal-most position, suchthat lateral aperture (24) of needle (20) is closed as shown in FIGS.9-11. As also noted herein, such insertion may be performed under visualguidance, stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, palpatory guidance, some other type ofguidance, or otherwise. With needle (20) sufficiently inserted into thepatient's breast, the user may then activate motor (36), which may inturn activate vacuum pump (38) and cutter actuation mechanism (100).Such activation of vacuum pump (38) may induce a vacuum in tissue sampleholder (40) and cutter lumen (52) as described above. Such activation ofcutter actuation mechanism (60) may cause cutter (50) to rotatecounterclockwise and translate proximally, as shown in FIGS. 12-14. Ascutter (50) starts retracting and when cutter (50) reaches the retractedposition, vacuum from vacuum pump (38) (as communicated through tissuesample holder (40) and cutter lumen (52)) may draw tissue into lateralaperture (24) of needle (20). During this time, second lumen (28) may bevented by valve mechanism (150).

Once cutter (50) reaches a proximal-most position, as shown in FIGS.15-17, vacuum may still be communicated through vacuum lumen (52) andfirst lumen (26), drawing tissue into lateral aperture (24) of needle(20). Second lumen (28) is substantially sealed by valve assembly (150)at this time, as shown in FIGS. 16-17. In addition, lead screw (122)freewheels yet is biased distally by spring (128) as cutter (50)continues to rotate counterclockwise. Lateral aperture (24) is fullyopen at this stage, with tissue prolapsed therein.

The rotation direction of motor (36) is then reversed and cutter (50)begins to advance distally until again reaching the distal-most positionas shown in FIGS. 18-20. As cutter (50) advances distally, vacuum isstill being communicated through vacuum lumen (52), helping to holdtissue in place as sharp distal edge (51) of cutter (50) begins to severthe tissue. Second lumen (28) is initially substantially sealed by valveassembly (150) at this time, but is eventually vented as shown in FIGS.19-20. Cutter (50) then reaches the distal-most position, as shown inFIGS. 18-20, thereby “closing” lateral aperture (24), and such thatsharp distal edge (51) of cutter (50) completely severs the tissue.Vacuum is still being communicated through cutter lumen (52) at thistime, and valve assembly (150) vents second lumen (28) as shown in FIGS.19-20. As described above, this combination of vacuum and ventingprovides communication of the severed tissue sample proximally throughcutter lumen (52) and into tissue sample holder (40). Motor (36) maycontinue to operate at the end of the cutting stroke, thereby continuingto drive vacuum pump (38) to maintain a vacuum in tissue sample holder(40). In addition, spring (130) biases lead screw (122) proximally toengage threads (132), while allowing cutter (50) to continue rotating atthe distal-most position. A cutting stroke will thus be complete, andmay be initiated as many times as desired to acquire additional tissuesamples.

As noted above, several cutting strokes may be performed to acquireseveral tissue samples without the user having to withdraw needle (20)from the patient's breast. The user may adjust the orientation oflateral aperture (24) about the axis defined by needle (20) by rotatingthe entire biopsy device (10) between cutting strokes for multiplesample acquisition. Alternatively, biopsy device (10) may be configuredsuch that needle (20) is rotatable relative to body (30), such thatneedle (20) may be rotated via a thumbwheel or other feature. Once thedesired number of tissue samples have been obtained, the user maywithdraw needle (20) from the patient's breast. The user may then removecap (42) from cup (44) and retrieve the tissue samples from filter tray(46).

At the end of a procedure, the user may separate probe (12) from holster(14).

Holster (14) may then be cleaned and/or sterilized for subsequent use.Probe (12) may be disposed of. Alternatively, as noted above, biopsydevice (10) may alternatively be formed as a unitary construction, suchthat there is no probe (12) separable from a holster (14).

It should be understood that any of a variety of operations may occur atthe end of a cutting stroke. For instance, biopsy device (10) mayprovide a variety of forms of feedback to inform the user that a cuttingstroke as been completed. By way of example only, biopsy device (10) mayprovide an electronic beep or other audible indication, a mechanicalaudible indication (e.g., a loud click), a visual indication (e.g., alight illuminating or flashing), or some other type of audible and/orvisual indication. Alternatively, and particularly in versions where cup(44) is transparent, the user may know that a cutting stroke is completeby simply watching tissue sample holder (40) until the user sees atissue sample being deposited on filter tray (46). Alternatively, acontrol module may be provided to automatically deactivate motor (36) assoon as a cutting stroke is complete, even if the user continues to holda trigger button (not shown) down. The user may then initiate anothercutting stroke by releasing and then re-pressing the trigger button. Asyet another merely illustrative example, and as noted above, a controlmodule may initiate a cutting stroke in response to the user brieflypressing or tapping a trigger button, and may automatically deactivatemotor (36) as soon as the cutting stroke is complete. The user may theninitiate another cutting stroke by briefly pressing or tapping thetrigger button again. Still other suitable ways in which biopsy device(10) may operate at the end of a cutting stroke and/or to initiate asubsequent cutting stroke will be apparent to those of ordinary skill inthe art in view of the teachings herein.

It should also be understood that circuit boards (35) may includecircuitry that is configured to automatically cause the rotationaldirection of motor (36) to reverse as soon as cutter (50) reaches theproximal-most position. For instance, one or more sensors (e.g., halleffect sensor, etc.) may track or otherwise sense the longitudinalposition of cutter (50). In addition or in the alternative, one or moresensors (e.g., encoder with encoder wheel, etc.) may track or otherwisesense the number of rotations of cutter (50), and control circuitry mayunderstand the longitudinal position of cutter (50) as a function of thenumber of rotations of cutter (50). As yet another alternative, motorreversal may be essentially manual (e.g., such that biopsy device (10)includes a “forward” button and a “reverse” button, etc.). Still othersuitable ways in which the rotational direction of motor (38) may bemanually or automatically reversed will be apparent to those of ordinaryskill in the art in view of the teachings herein. It should also beunderstood that one or both circuit boards (35) may continue to operatemotor (36) at least temporarily (e.g., for a few seconds, etc.) at theend of each cutter (50) stroke (e.g., while cutter (50) remains at thedistal-most position and/or at the proximal-most position), such as tocontinue to operate vacuum pump (38).

In versions of biopsy device (10) where an electronic based audibleand/or visual indication of the end of a cutting stroke is provided, aswell as versions of biopsy device (10) where a control moduleautomatically deactivates motor (36) or disengages a clutch or providessome other type of automated response, there are a variety of ways inwhich the end of a cutting stroke may be sensed. For instance, a portionof cutter (50) may include a magnet, and a hall effect sensor may bepositioned in body (30) to sense the presence of the magnet when cutter(50) reaches the distal-most position at the end of a cutting stroke. Asanother merely illustrative example, an encoder wheel may be coupledwith cutter (50) or a rotating component of cutter rotation mechanism(60), such that the longitudinal position of cutter (50) may bedetermined based on a number of rotations. Other suitable ways in whichthe end of a cutting stroke may be sensed (e.g., electronically,mechanically, electro-mechanically, manually, etc.) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

Of course, the above examples of use of biopsy device (10) are merelyillustrative. Other suitable ways in which biopsy device (10) may beused will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times.

Embodiments may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, embodiments of the device may be disassembled, and anynumber of the particular pieces or parts of the device may beselectively replaced or removed in any combination. Upon cleaning and/orreplacement of particular parts, embodiments of the device may bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device mayutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometries, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1. A biopsy device, comprising: (a) a needle; (b) a cutter, wherein thecutter is configured to translate and rotate relative to the needle tosever tissue; and (c) a cutter actuation mechanism, wherein the cutteractuation mechanism comprises a first rotating member and a secondrotating member, wherein the first rotating member is configured torotate the cutter, wherein the second rotating member is configured totranslate the cutter, wherein the cutter actuation mechanism isconfigured such that the first rotating member and the second rotatingmember rotate simultaneously at different rotational speeds.
 2. Thebiopsy device of claim 1, wherein the cutter comprises an integralmember secured to the cutter, wherein the integral member comprises afirst portion configured to engage the first rotating member, whereinthe integral member further comprises a second portion configured toengage the second rotating member.
 3. The biopsy device of claim 2,wherein the cutter and the integral member are operable to translatealong an axis about which the second member rotates.
 4. The biopsydevice of claim 2, wherein the first portion of the integral membercomprises an external lead screw.
 5. The biopsy device of claim 4,wherein the first rotating member comprises an internal threadingconfigured to threadingly engage the external lead screw.
 6. The biopsydevice of claim 2, wherein the first portion of the integral membercomprises at least one external flat portion.
 7. The biopsy device ofclaim 6, wherein the second rotating member comprises at least oneinterior flat portion configured to complement the at least one externalflat portion of the integral member.
 8. The biopsy device of claim 2,wherein the second rotating member is operable to rotate the first andsecond portions of the integral member simultaneously at a firstrotational speed, wherein the first rotating member is operable torotate at a second rotational speed, while the second rotating memberrotates the first and second portions of the integral member at thefirst rotational speed, to provide rotation of the first rotating memberrelative to the first portion of the integral member at a thirdrotational speed, the third rotational speed being the differencebetween the first rotational speed and the second rotational speed. 9.The biopsy device of claim 2, wherein the first portion of the integralmember and the first rotating member are configured to cooperate totranslate the cutter when the first rotating member rotates while thecutter is positioned within a certain longitudinal range, wherein thefirst portion of the integral member and the first rotating member arefurther configured to substantially maintain the longitudinal positionof the cutter when the first rotating member rotates while the cutter ispositioned outside the certain longitudinal range.
 10. The biopsy deviceof claim 9, wherein the second portion of the integral member and thesecond rotating member are configured to rotate the cutter while thecutter is positioned within the certain longitudinal range and while thecutter is positioned outside the certain longitudinal range.
 11. Thebiopsy device of claim 2, wherein the cutter comprises metal, whereinthe integral member comprises a unitary piece of plastic, wherein theintegral member is overmolded about the cutter.
 12. The biopsy device ofclaim 1, wherein the cutter actuation mechanism further comprises anelectric motor configured to drive the first and second rotatingmembers.
 13. The biopsy device of claim 12, further comprising ahandheld body, wherein the needle extends distally from the handheldbody, wherein the cutter actuation mechanism is contained within thebody.
 14. The biopsy device of claim 13, wherein the body comprises aprobe portion and a holster portion, wherein the probe portion isremovably coupled with the holster portion.
 15. The biopsy device ofclaim 14, wherein the needle extends distally from the probe portion,wherein the electric motor is contained within the holster portion. 16.The biopsy device of claim 1, wherein the needle defines a transverseaperture, wherein the cutter is disposed within the needle, wherein thecutter defines a lumen, wherein the biopsy device is operable tocommunicate severed tissue samples proximally through the lumen of thecutter.
 17. A biopsy device, comprising: (a) a needle; (b) a cutter,wherein the cutter is configured to translate and rotate relative to theneedle to sever tissue, wherein the cutter has an integral member havinga first portion and a second portion; and (c) a cutter actuationmechanism, wherein the cutter actuation mechanism comprises: (i) a firstrotating member engaged with the first portion of the integral member totranslate the cutter relative to the needle, and (ii) a second rotatingmember engaged with the second portion of the integral member to rotatethe cutter relative to the needle, wherein the cutter actuationmechanism is operable to rotate the first and second rotating memberssimultaneously in the same direction at different rotational speeds. 18.The biopsy device of claim 17, wherein the first portion of the integralmember comprises an external lead screw, wherein the first rotatingmember is disposed about the first portion of the integral member andcomprises a nut engaged with the external lead screw, wherein the secondportion of the integral member comprises an external flat portion,wherein the second rotating member is disposed about the second portionof the integral member and comprises an internal flat portion engagedwith the external flat portion.
 19. A biopsy device, comprising: (a) abody, wherein the body is configured to be handheld; (b) a needleextending distally from the body; (c) a cutter, wherein the cutter isconfigured to translate and rotate relative to the needle to severtissue, wherein the cutter has an integral member having a first portionand a second portion; and (d) a cutter actuation mechanism, wherein thecutter actuation mechanism comprises: (i) a first rotating memberengaged with the first portion of the integral member to translate thecutter relative to the needle, wherein the cutter actuation mechanism isoperable to rotate the first rotating member relative to the body at afirst rotational speed, and (ii) a second rotating member engaged withthe second portion of the integral member to rotate the cutter relativeto the needle, wherein the cutter actuation mechanism is operable torotate the second rotating member relative to the body at a secondrotational speed while rotating the first rotating member relative tothe body at the first rotational speed.
 20. The biopsy device of claim19, wherein the second rotating member rotates the first and secondportions of the integral member relative to the body at the secondrotational speed, to provide rotation of the first rotating memberrelative to the first portion of the integral member at a thirdrotational speed, the third rotational speed being the differencebetween the first rotational speed and the second rotational speed.